After a few days of investor anxiety, Arcutis Biotherapeutics announced that the FDA has approved ZORYVE for a new indication: atopic dermatitis. The FDA was scheduled to announce its decision on ZORYVE (roflumilast) for this new use on the 7th of this month, but the date passed without news. In an uncommon move to calm shareholders’ concerns, Arcutis released a statement indicating no new information had been requested and that they anticipated receiving a letter from the regulator shortly.
Later on July 09, confirmation was finally received: ZORYVE had been approved as a new, once-daily treatment for mild to moderate atopic dermatitis in adults and children aged ...